Nuquin HP Cream

Name: Nuquin HP Cream

Nuquin HP Cream Description

Each gram of NUQUIN® HP 4% CREAM contains ACTIVES: 40mg Hydroquinone USP, 80mg of Padimate O, 30mg of Dioxybenzone and 20mg of Oxybenzone in a cream base of INACTIVES: Cetostearyl Alcohol, Glycerine, Mineral Oil, Polysorbate-60, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sorbic Acid and White Petrolatum.

Hydroquinone is 1, 4-Benzenediol. Hydroquinone is structurally related to monobenzone. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol and has a pKa of 9.96. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6H6O2 and has a molecular weight of 110.11.

The structural formula is:

C6H602

Nuquin HP Cream - Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (dopa) [Denton, C., et al., 19521] and suppression of other melanocyte metabolic processes [Jimbow, K., et al., 19742]. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas [Parrish, J.A. et al., 1978].

Adverse Reactions

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.

Overdosage

There have been no systemic reactions reported from the use of topical hydroquinone treatment. However, treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Hydroquinone references

1. Denton, C., Lerner, A., and Fitzpatrick, T., "Inhibition of Melanin Formation by Chemical Agents", J. Invest. Derm., 18:119-135, 1952.

2. Jimbow, K., Obata, M., Pathak, M., and Fitzpatrick, T., "Mechanisms of Depigmentation by Hydroquinone", J. Invest. Derm., 62:436-449, 1974.

3. Parrish, J, Anderson, R., Urbach, F., and Pitts, D., " Biological Effects of Ultraviolet Radiation with Emphasis on Human Responses to Longwave Ultraviolet", Plenum Press, New York, 1978 (page 151).

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

NDC 58980-574-10
Net WT. 1 OZ (28.4g)

NUQUIN® HP 4% CREAM

STRATUS
PHARMACEUTICALS INC

(HYDROQUINONE USP, 4%)
SKIN BLEACHING CREAM WITH SUNSCREENS

Rx only

Distributed by Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

NUQUIN HP 
hydroquinone, padimate o, dioxybenzone, and oxybenzone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-574
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
Padimate O (Padimate O) Padimate O 80 mg  in 1 g
Dioxybenzone (Dioxybenzone) Dioxybenzone 30 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Water  
GLYCERIN  
PETROLATUM  
CETOSTEARYL ALCOHOL  
SORBIC ACID  
Mineral Oil  
POLYSORBATE 60  
SODIUM LAURYL SULFATE  
SODIUM METABISULFITE  
PROPYLENE GLYCOL  
Product Characteristics
Color YELLOW (Light) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:58980-574-10 1 TUBE in 1 BOX
1 28.4 g in 1 TUBE
2 NDC:58980-574-20 1 TUBE in 1 BOX
2 56.7 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/09/2003
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc. 104283945 MANUFACTURE(58980-574)
Revised: 11/2014   Stratus Pharmaceuticals
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